Alleged Conflict of Interest on FDA Tobacco Panel

U.S. District Court Judge Richard Leon has allowed a lawsuit seeking an injunction by R.J. Reynolds and Lorillard Tobacco to proceed against the Tobacco Products Scientific Advisory Committee. It alleges a conflict of interest on the scientific panel responsible for regulating tobacco products.

FDA officials asked Judge Leon to deny the request but the judge rebuffed their claim, noting in his ruling “the limited number of viewpoints on these issues” and “the scientific as opposed to the political nature of those viewpoints, and the distinct responsibilities of the committee.”

Drug Companies Conflicts

At issue is the membership of the Center for Tobacco Products’ Tobacco Science Advisory Committee (TPSAC). TPSAC was created after passage of the Family Smoking Prevention and Tobacco Control Act. TPSAC has eight members, three of whom allegedly present a conflict of interest with pharmaceutical companies that could benefit from anti-smoking regulations.

Federal law says FACA members may not have an interest in activities in which the committee is involved. This includes stock holdings or contracts with companies that may be affected by the committee’s recommendations. FDA Commissioner Margaret Hamburg has refused to remove these three members after repeated requests from industry and government ethics groups to do so.

Anti-Smoking Leader’s Support

Dr. Michael Siegel, a major anti-smoking researcher and professor at Boston University School of Public Health, supports the lawsuit and wrote on his blog, “there is a sufficient legal basis for the suit to move forward.” Siegel added, “… it is inexcusable to allow these financially conflicted members to serve on the FDA advisory panel.”

Some anti-tobacco groups claim there is nothing wrong with allowing these members to remain on the panel. Vince Wilmore, spokesperson for the Campaign for Tobacco Free Kids, believes the lawsuit is just a means “to obstruct effective policies to reduce tobacco use and to discredit anyone who advocates such policies.”

But Siegel argues Campaign for Tobacco Free Kids’ rhetoric ignores the central legal question. “That rhetoric may have worked years ago,” he wrote, “but we are now living in a new era, when (ironically, thanks to the Campaign for Free Kids), tobacco companies are now under federal regulation. And with federal regulation the law must be obeyed.”

Investigation Request

As far back as 2010, Citizens for Responsibility and Ethics in Washington (CREW) sent a letter to the Inspector General calling for an investigation into the TPSAC and the conflict of interest of several of its members. CREW singles out Drs. Neal Benowitz and Jack Henningfield, both of whom have consulting connections with pharmaceutical companies, to develop smoking cessation products. Benowitz works for Pfizer, the maker of Chantix, a smoking cessation drug. Henningfield consults with the maker of Nicorette gum. A third member of the panel, Dorothy Hatsukami, has received grants to study the effects of a nicotine vaccine.

Jeff Edgens(jedgens@gmail.com)is an assistant professor of political science at East Georgia State College and an adjunct scholar with the Competitive Enterprise Institute.